As previously reported on a Current Report on Form 8-K, on March 10, 2021, INmune Bio Inc. (the "Company"), entered into an At-The-Market Sales Agreement (the "Sales Agreement") with BTIG, LLC ("BTIG"), pursuant to which the Company may offer and sell, from time to time, through BTIG, as sales agent, shares of its common stock, par value $0.001 per share (the "Common Stock"), having an aggregate offering price of up to $45,000,000, subject to certain limitations on the amount of Common Stock that may be offered and sold by the Company set forth in the Sales Agreement (Filing, 8-K, INmune Bio, AUG 16, 2023, View Source [SID1234634452]). The Company is not obligated to make any sales of Common Stock under the Sales Agreement and any determination by the Company to do so will be dependent, among other things, on market conditions and the Company’s capital raising needs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On August 16, 2023, the Company and BTIG entered into Amendment No. 1 to the Sales Agreement ("Amendment No. 1 to the Sales Agreement") in order to provide that the offers and sales of Common Stock by the Company under the Sales Agreement, as amended, if any, will be made through a prospectus supplement to the prospectus forming a part of the Company’s shelf registration statement on Form S-3 (File No. 333-254221) declared effective by the Securities and Exchange Commission (the "SEC") on May 5, 2021 (the "Registration Statement"). The Company filed with the SEC a prospectus supplement dated August 16, 2023, specifically relating to offers and sales of Common Stock under the Sales Agreement (the "ATM Prospectus Supplement"), together with the prospectus forming a part of the effective registration statement.

Shares may be sold through the ATM Prospectus Supplement by any method deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including sales made through The Nasdaq Capital Market or any other trading market for the common stock, sales made to or through a market maker other than on an exchange or through an electronic communications network, or in negotiated transactions pursuant to terms set forth in a placement notice delivered by the Company to BTIG under the Sales Agreement. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, BTIG will use commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations, and the rules of The Nasdaq Capital Market, to sell the Shares from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. BTIG is not obligated to purchase any shares of Common Stock on a principal basis pursuant to the Sales Agreement.

The foregoing description of Amendment No. 1 to the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment No. 1 to the Sales Agreement. A copy of the Amendment No. 1 to the Sales Agreement is filed with this Current Report on Form 8-K as Exhibit 1.1 and is incorporated herein by reference.

A copy of the opinion of Sichenzia Ross Ference LLP relating to the validity of the Shares that may be offered and sold under the ATM Prospectus Supplement, is filed with this Current Report on Form 8-K as Exhibit 5.1.

This Current Report on Form 8-K does not constitute an offer to sell or the solicitation of offers to buy any securities of the Company, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On August 16, 2023 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us"), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, reported that additional NXC-201 clinical data for relapsed/refractory AL Amyloidosis has been selected for oral presentation at the 20th International Myeloma Society Annual Meeting to be held in Athens, Greece, September 27-30, 2023 (Press release, Immix Biopharma, AUG 16, 2023, View Source [SID1234634451]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to present additional clinical data in the NEXICART-1 clinical study evaluating NXC-201 in patients with relapsed/refractory light chain AL amyloidosis at the upcoming International Myeloma Society Annual Meeting in September," said Polina Stepensky, M.D., Director of the Hadassah Medical Organization’s Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and NXC-201 principal study investigator. "We continue to make progress in this important indication, in the hope of providing patients with new treatment options."

Poster Presentation Details:

Event 20th International Myeloma Society Annual Meeting, Athens, Greece
Title "Feasibility of a novel academic anti-BCMA chimeric antigen receptor T-cell (CART) (HBI0101) for the treatment of relapsed and refractory AL amyloidosis"
Presentation
Date/Time (EEST)
September 27, 2023 9:00am – 14:30pm;
September 28, 2023 10:00 – 13:30pm;
September 29, 2023 9:30 – 14:15pm
About NXC-201
NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.

About NEXICART-1
NEXICART-1 (NCT04720313) is Phase 1b/2a, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis.
The primary objective of the Phase 1b portion of the study is to characterize the safety and confirm the recommended Phase 2 dose (RP2D) of NXC-201. The Phase 2 portion of the study will evaluate the efficacy and safety of NXC-201 in relapsed/refractory Multiple Myeloma (R/R MM) patients, according to the International Myeloma Working Group (IMWG) Uniform Response Criteria and in relapsed/refractory AL Amyloidosis (R/R ALA) according to consensus recommendations.
The Phase 1b portion of the ongoing Phase 1b/2a clinical trial has been successful in determining the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells. Nexcella plans to submit an IND application to the FDA for a Phase 1b/2 of NXC-201 in R/R MM and R/R ALA in order to expand the ongoing clinical trial to the U.S.
The expected primary endpoint for the Phase 2 portion of the ongoing trial in R/R MM is overall response rate and duration of response. Nexcella plans to submit data to the FDA once 100 patients have been treated. The expected primary endpoint for NXC-201 in R/R ALA is overall response rate. Nexcella plans to submit data to the FDA once 30-40 patients have been treated.

About AL Amyloidosis
AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded amyloid proteins produced by these cells cause a buildup of misfolded immunoglobulin proteins in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage and high mortality rates.
AL amyloidosis affects roughly 30,000 – 40,000 patients in the U.S. and Europe, and it is estimated that there are approximately 3,000 – 4,000 new cases annually in the U.S. The estimated annual global incidence ~15,000 patients.
The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, according to Grand View Research.

On August 16, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported that the Compensation Committee of the company’s Board of Directors granted two employees nonqualified stock options to purchase an aggregate of 32,500 shares of its common stock with an exercise price of $1.70, which is equal to the closing price of Gritstone’s common stock on August 7, 2023, the date of the grant (Press release, Gritstone Bio, AUG 16, 2023, View Source [SID1234634450]). These stock options are part of an inducement material to the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates. The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.

On August 16, 2023 Gilead Sciences presented its corporate presentation (Presentation, Gilead Sciences, AUG 16, 2023, View Source [SID1234634449]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On August 16, 2023 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported that the first patient has been dosed in the Phase 1 clinical trial evaluating EO-3021 in patients with advanced unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers (Press release, Elevation Oncology, AUG 16, 2023, View Source;utm_medium=rss&utm_campaign=elevation-oncology-announces-first-patient-dosed-in-the-phase-1-clinical-trial-evaluating-eo-3021 [SID1234634448]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The dosing of the first patient is a major milestone in evaluating EO-3021’s potential benefit for these patients," said Valerie Malyvanh Jansen, M.D., Ph.D., Chief Medical Officer of Elevation Oncology. "Claudin 18.2 has emerged as a promising therapeutic target in gastric cancer and other solid tumors. Based on preclinical and early clinical data, EO-3021 represents a potentially safer and more effective therapeutic option for patients with advanced solid tumors that likely express Claudin 18.2, including gastric and gastroesophageal junction cancers. We look forward to evaluating the potential of EO-3021 and expect to report preliminary data on safety and anti-tumor activity from our Phase 1 study during the first half of 2025."

Meredith Pelster, M.D., MSCI, Assistant Director of Gastrointestinal Research for Sarah Cannon Research Institute and a principal investigator in the Phase 1 study of EO-3021, added, "Targeting Claudin 18.2 with an antibody-drug conjugate represents a promising therapeutic option for patients. The initial clinical data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting point to a safe and tolerable therapy that can induce deep responses in patients with gastric cancer. EO-3021 has the potential to provide a much-needed treatment option for patients with advanced solid tumors likely to express Claudin 18.2."

EO-3021 is a potential best-in-class antibody-drug conjugate (ADC) that has been designed to selectively deliver a cytotoxic payload directly to Claudin 18.2-expressing cancer cells to minimize payload-associated toxicities and maximize anti-tumor activity. EO-3021 is a fully human monoclonal antibody that targets Claudin 18.2 and is site-specifically conjugated to the cytotoxic agent monomethyl auristatin E via a cleavable linker, with a drug-to-antibody ratio of 2.

Elevation Oncology’s Phase 1 clinical trial (NCT05980416) is an open-label, multi-center dose escalation and expansion study that is expected to enroll up to approximately 120 patients to evaluate the safety, tolerability, and preliminary anti-tumor activity of EO-3021 in advanced solid tumors likely to express Claudin 18.2. The dose escalation portion of the study will enroll patients with advanced unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction, pancreatic or esophageal cancers. The expansion portion of the study is expected to further evaluate EO-3021 in patients with advanced unresectable or metastatic gastric or gastroesophageal junction cancers. An additional objective of the study will be to assess the association of Claudin 18.2 expression and objective response. Elevation Oncology expects to report preliminary safety and anti-tumor data from its Phase 1 study during the first half of 2025.

CSPC Pharmaceutical Group Limited (HKEX: 01093), is also evaluating SYSA1801 (EO-3021) in an ongoing Phase 1 clinical trial in China (NCT05009966). Preliminary data from CSPC’s Phase 1 study were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting. The findings showed promising early signs of EO-3021 activity, including an objective response rate of 47.1% in patients with gastric cancer (8 PRs, including 4 confirmed PRs) and a disease control rate of 64.7%, along with a well-tolerated safety profile in patients with resistant/refractory tumors expressing Claudin 18.2. Elevation Oncology has licensed the exclusive rights to develop and commercialize EO-3021 in all global territories outside Greater China from CSPC.

About EO-3021

EO-3021 (also known as SYSA1801) is a differentiated, clinical-stage antibody drug conjugate (ADC) comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and is site-specifically conjugated to the monomethyl auristatin E (MMAE) payload via a cleavable linker with a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is normally expressed in gastric epithelial cells. During malignant transformations, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Elevation Oncology is evaluating EO-3021 in a Phase 1 study in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers.